Renee Bailey

Apr 6, 2024 | meddeviceonline.com | Edwin L. Bills |Christie Johnson |Jayet Moon |Renee Bailey

On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.

Nov 17, 2023 | med-technews.com | Renee Bailey

Renée Bailey, senior manager, human factors engineering, BlackHӓgen Design explains how to avoid deficiencies in submissions with use-related risk analysis. For companies seeking approval of their medical device in the U.S., the Food & Drug Administration (FDA)’s expectations often come as a surprise.

Sep 20, 2023 | medtechintelligence.com | Renee Bailey

In the rapidly advancing world of medical devices, ensuring user safety and optimal performance is paramount. This calls for meticulous attention not only to the design of the devices themselves, but also to the instructional materials that accompany them. The efficacy of these instructional materials, whether intended for lay users (e.g., patients and caregivers) or healthcare professionals, plays a vital role in establishing safe and effective interactions between end users and medical devices.